ID

43619

Descripción

Study ID: 100551 (EXT Y11) Clinical Study ID: 100551 Study Title: A double blind randomised, comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B vaccine when administered in healthy adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289770 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Palabras clave

Versiones (3)
  1. 16/6/17 16/6/17 -
  2. 19/9/17 19/9/17 -
  3. 20/9/21 20/9/21 -
Subido en

20 de septiembre de 2021

DOI

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Licencia

Creative Commons BY-NC 3.0
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Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 19 Year 13)

Inglés

Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 19 Year 13)

1 formularios  
General Information
Descripción

General Information

Alias
UMLS CUI-1
C1508263
Centre number
Descripción

Centre number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Subject number
Descripción

Subject number

Tipo de datos

integer

Alias
UMLS CUI [1]
C2348585
General Instructions
Descripción

Print clearly in CAPITAL LETTERS using a black fountain or ball-point pen and press firmly so that all copies are legible. Insert the writing board beneath all copies of the form being completed. Fill in the Subject Number on every page and answer all questions except where otherwise indicated. Do not write in shaded areas which are qualified “For GSK”. Information written in these areas are not the responsibility of the investigator. ABBREVIATIONS: Abbreviations for medical conditions, clinical events or drug names should not be used. Units and route of administration of medication may be abbreviated. NA: not applicable. ERRORS/CORRECTIONS: Errors should be crossed out with a single line and the alteration made as near to the original as possible. All alterations must be printed, initialled and dated by the investigator or authorised staff. DATES Use the following three-letter abbreviations for each month: January = JAN February = FEB March = MAR April = APR May = MAY June = JUN July = JUL August = AUG September = SEP October = OCT November = NOV December = DEC Example: |__|__| |__|__|__| |__|__|__|__|= 1st January 2002 day month year The Serious Adverse Event (SAE) form must be checked for final assessment at the end of the study. For all subjects enrolled, please complete the Study Conclusion form. ADVERSE EVENT DEFINITIONS INTENSITY 1: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. 2: Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. 3: Severe: An adverse event which prevents normal, everyday activities (In adults/ adolescents, such an adverse event would, for example, prevent attendance at work/school and would necessitate the administration of corrective therapy). CAUSALITY / RELATIONSHIP TO INVESTIGATIONAL PRODUCTS Is there a reasonable possibility that the AE may have been caused by the investigational product? NO: The adverse event is not causally related to administration of the study vaccine(s). There are other, more likely causes and administration of the study vaccine(s) is not suspected to have contributed to the adverse event. YES: There is a reasonable possibility that the vaccine contributed to the adverse event. OUTCOME 1: Recovered / Resolved 2: Recovering / Resolving: If the subject is recovering at the time the subject completes the study or at the time the subject dropped out 3: Not recovered / Not resolved: This means an AE ongoing at the time the subject completes the study or becomes lost to follow-up; if AE/SAE was ongoing at the time of death, but was not the cause of death. 4: Recovered with sequelae / Resolved with sequelae SERIOUS ADVERSE EVENT A serious adverse event is any untoward medical occurrence that: • results in death • is life threatening • results in persistent or significant disability / incapacity • requires in-patient hospitalization • prolongation of existing hospitalization • is a congenital anomaly / birth defect in the offspring of a study subject • In addition, important medical events that may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above should be considered serious. (Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization.) For each serious adverse event, please fill in the Serious Adverse Event (SAE) form and contact GlaxoSmithKline within 24 hours. Informed Consent has to be obtained prior to any study procedure.

Tipo de datos

text

Alias
UMLS CUI [1]
C1508263
Informed Consent Date
Descripción

I certify that Informed Consent has been obtained prior to any study procedure.

Tipo de datos

date

Alias
UMLS CUI [1]
C0021430
Demographics
Descripción

Demographics

Alias
UMLS CUI-1
C1704791
Center number
Descripción

Center number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of birth
Descripción

Date of birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
Gender
Descripción

Gender

Tipo de datos

text

Alias
UMLS CUI [1]
C0079399
Race
Descripción

Race

Tipo de datos

text

Alias
UMLS CUI [1]
C0034510
Laboratory tests
Descripción

Laboratory tests

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
Descripción

anti-HAV and anti-HBs antibodies

Tipo de datos

text

Alias
UMLS CUI [1]
C0201473
UMLS CUI [2]
C0201478
Date of Blood Sample
Descripción

Please complete only if different from visit date

Tipo de datos

date

Alias
UMLS CUI [1]
C1317250
Has the subject received a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine sind the last visit?
Descripción

Hepatitis A or Hepatitis B vaccine

Tipo de datos

text

Alias
UMLS CUI [1]
C0170300
UMLS CUI [2]
C2240392
Please specify
Descripción

Hepatitis A or Hepatitis B vaccine: Specification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0170300
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C2240392
UMLS CUI [2,2]
C2348235
A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
Descripción

Hepatitis A or Hepatitis B immunoglobulins

Tipo de datos

text

Alias
UMLS CUI [1]
C3652495
UMLS CUI [2]
C0062525
Please specify
Descripción

Hepatitis A or Hepatitis B immunoglobulins: Specification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C3652495
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C0062525
UMLS CUI [2,2]
C2348235
Would the subject be willing to participate in a follow-up study?
Descripción

Follow-up studies

Tipo de datos

text

Alias
UMLS CUI [1]
C0016441
Adverse Events, or Serious Adverse Events
Descripción

Adverse Events, or Serious Adverse Events

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0877248
UMLS CUI [2]
C1519255
please specify
Descripción

Adverse Events, or Serious Adverse Events: Specification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2348235
UMLS CUI [2,1]
C1519255
UMLS CUI [2,2]
C2348235
Other
Descripción

Other

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0205394
Please specify
Descripción

Other: Specification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C2348235
Study Conclusion
Descripción

Study Conclusion

Alias
UMLS CUI-1
C1707478
Did the subject experience any Serious Adverse Event during the study period?
Descripción

Occurence of Serious Adverse Event

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C2745955
Total number of SAE´s
Descripción

Number of SAE´s

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0449788
UMLS CUI [1,2]
C1519255
Did the subject become pregnant during the study?
Descripción

Pregnancy

Tipo de datos

text

Alias
UMLS CUI [1]
C0032961
Investigator´s signature
Descripción

Investigator´s signature

Alias
UMLS CUI-1
C2346576
Text to confirm
Descripción

I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.

Tipo de datos

text

Alias
UMLS CUI [1]
C0750484
Investigator´s signature
Descripción

Investigator´s signature

Tipo de datos

text

Alias
UMLS CUI [1]
C2346576
Date
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
Printed Investigator´s name name
Descripción

Investigator´s name

Tipo de datos

text

Alias
UMLS CUI [1]
C2826892
Tracking Document - Reason for non participation
Descripción

Tracking Document - Reason for non participation

Alias
UMLS CUI-1
C3889409
Previous subject number
Descripción

Previous subject number

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C2348585
UMLS CUI [1,2]
C0205156
Date of birth
Descripción

Date of birth

Tipo de datos

date

Alias
UMLS CUI [1]
C0421451
1. Subject not eligible?
Descripción

Eligibility

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013893
Please specify criteria that are not fullfilled
Descripción

Eligibility: Specification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0013893
UMLS CUI [1,2]
C2348235
Subject lost to follow-up or not reached
Descripción

Lost to follow-up

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1302313
Subject eligible but not willing to participate due to
Descripción

Willing to participate

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0600109
UMLS CUI [1,2]
C2348568
Specification of reason not willing to participate
Descripción

Willing to participate: Specification

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0600109
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C2348235
Subject died on
Descripción

Date of death

Tipo de datos

date

Alias
UMLS CUI [1]
C1148348
Investigator name
Descripción

Investigator name

Tipo de datos

text

Alias
UMLS CUI [1]
C2826892
Signature
Descripción

Signature

Tipo de datos

text

Alias
UMLS CUI [1]
C1519316
Date
Descripción

Date

Tipo de datos

date

Alias
UMLS CUI [1]
C0011008
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Similar models

Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 19 Year 13)

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
General Information
C1508263 (UMLS CUI-1)
Centre number
Item
Centre number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
General Instructions
Item
General Instructions
text
C1508263 (UMLS CUI [1])
Informed Consent
Item
Informed Consent Date
date
C0021430 (UMLS CUI [1])
Item Group
Demographics
C1704791 (UMLS CUI-1)
Center number
Item
Center number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
male (1)
CL Item
female (2)
Item
Race
text
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
Black (1)
CL Item
Arabic/North African (2)
CL Item
White/Caucasian (3)
CL Item
East & South East Asian (4)
CL Item
South Asian (5)
CL Item
American Hispanic (6)
CL Item
Japanese (7)
CL Item
Other, please specify (8)
Item Group
Laboratory tests
C0022885 (UMLS CUI-1)
Item
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
text
C0201473 (UMLS CUI [1])
C0201478 (UMLS CUI [2])
anti-HAV and anti-HBs antibodies
Code List
Has a blood sample been taken for testing anti-HAV and anti-HBs antibodies?
CL Item
Yes (Please complete the following question) (1)
CL Item
No (2)
Date of blood sample
Item
Date of Blood Sample
date
C1317250 (UMLS CUI [1])
Item
Has the subject received a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine sind the last visit?
text
C0170300 (UMLS CUI [1])
C2240392 (UMLS CUI [2])
Has the subject received a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine sind the last visit?
Code List
Has the subject received a dose of monovalent or combined Hepatitis A or Hepatitis B vaccine sind the last visit?
CL Item
Yes (please answer the next item) (1)
CL Item
No (2)
Item
Please specify
text
C0170300 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C2240392 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Specification of monovalent or combined Hepatitis A or Hepatitis B vaccine
Code List
Please specify
CL Item
Hepatitis A vaccine (1)
CL Item
Hepatitis B vaccine (2)
CL Item
Combined Hepatitis A and B vaccine (3)
Item
A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
text
C3652495 (UMLS CUI [1])
C0062525 (UMLS CUI [2])
dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding
Code List
A dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding?
CL Item
Yes (please specify) (1)
CL Item
No (2)
Item
Please specify
text
C3652495 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C0062525 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Specification of dose of Hepatitis A or Hepatitis B immunoglobulins within 6 months prior to bleeding
Code List
Please specify
CL Item
Hepatitis A immunoglobulins (1)
CL Item
Hepatitis B immunoglobulins (2)
Item
Would the subject be willing to participate in a follow-up study?
text
C0016441 (UMLS CUI [1])
Follow-up studies
Code List
Would the subject be willing to participate in a follow-up study?
CL Item
Yes (1)
CL Item
No, please specify the most appropriate reason below (2)
Adverse Events, or Serious Adverse Events
Item
Adverse Events, or Serious Adverse Events
boolean
C0877248 (UMLS CUI [1])
C1519255 (UMLS CUI [2])
Adverse Events, or Serious Adverse Events: Specification
Item
please specify
text
C0877248 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C2348235 (UMLS CUI [2,2])
Other
Item
Other
boolean
C0205394 (UMLS CUI [1])
Other: Specification
Item
Please specify
text
C0205394 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
Item
Did the subject experience any Serious Adverse Event during the study period?
text
C1519255 (UMLS CUI [1,1])
C2745955 (UMLS CUI [1,2])
Occurence of Serious Adverse Event
Code List
Did the subject experience any Serious Adverse Event during the study period?
CL Item
No (1)
CL Item
Yes (Specify total number of SAE´s below) (2)
Number of SAE´s
Item
Total number of SAE´s
integer
C0449788 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
Item
Did the subject become pregnant during the study?
text
C0032961 (UMLS CUI [1])
Pregnancy information
Code List
Did the subject become pregnant during the study?
CL Item
No (1)
CL Item
Yes (Complete the Pregnancy Notification form) (2)
CL Item
Not Applicable (not of childbearing potential or male) (3)
Item Group
Investigator´s signature
C2346576 (UMLS CUI-1)
Confirmation
Item
Text to confirm
text
C0750484 (UMLS CUI [1])
Investigator´s signature
Item
Investigator´s signature
text
C2346576 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
Investigator´s name
Item
Printed Investigator´s name name
text
C2826892 (UMLS CUI [1])
Item Group
Tracking Document - Reason for non participation
C3889409 (UMLS CUI-1)
Previous subject number
Item
Previous subject number
integer
C2348585 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Eligibility
Item
1. Subject not eligible?
boolean
C0013893 (UMLS CUI [1])
Eligibility: Specification
Item
Please specify criteria that are not fullfilled
text
C0013893 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Lost to follow-up
Item
Subject lost to follow-up or not reached
boolean
C1302313 (UMLS CUI [1])
Item
Subject eligible but not willing to participate due to
text
C0600109 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Subject eligible but not willing to participate due to
Code List
Subject eligible but not willing to participate due to
CL Item
adverse events, or serious adverse event (please specifiy) (1)
CL Item
other (please specify) (2)
Willing to participate: Specification
Item
Specification of reason not willing to participate
text
C0600109 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
Date of death
Item
Subject died on
date
C1148348 (UMLS CUI [1])
Investigator name
Item
Investigator name
text
C2826892 (UMLS CUI [1])
Signature
Item
Signature
text
C1519316 (UMLS CUI [1])
Date
Item
Date
date
C0011008 (UMLS CUI [1])
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